1.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
2.Solitary Fibrous Tumor in Buccal Cheek Mucosa.
Chung Min YOON ; Jeong Min CHO ; Kwang Ryeol LIM ; Seok Kwun KIM ; Su Jin KIM ; Keun Cheol LEE
Archives of Craniofacial Surgery 2017;18(3):218-221
A solitary fibrous tumor is a relatively uncommon neoplasm that usually occurs in the pleura but occurs extremely rarely in the oral cavity. Reported herein is a rare case of a solitary fibrous tumor in the buccal cheek mucosa. A 50-year-old man visited the authors' hospital due to a buccal cheek mass whose size had increased. Excisional biopsy was done under local anesthesia. After the excisional biopsy, the patient was diagnosed to have a solitary fibrous tumor. In immunohistochemistry, the patient's solitary fibrous tumor was characterized by the expression of CD34 and CD99 on the neoplastic cells, and negativity for Bcl-2 and S-100. No recurrence or complication occurred for a period of 5 years. The growth of a primary solitary fibrous tumor in the buccal cheek mucosa is extremely rare and has been rarely reported in the South Korean medical literature. A solitary fibrous tumor must be distinguished from other spindle cell tumors. Presented herein is a case of primary solitary fibrous tumor in the buccal cheek mucosa. The relevant literature is briefly reviewed.
Anesthesia, Local
;
Biopsy
;
Cheek*
;
Humans
;
Immunohistochemistry
;
Middle Aged
;
Mouth
;
Mouth Mucosa
;
Mucous Membrane*
;
Pleura
;
Recurrence
;
Solitary Fibrous Tumors*
3.The Efficacy of Coblator in Turbinoplasty.
Keun Cheol LEE ; Jeong Min CHO ; Seok Kwun KIM ; Kwang Ryeol LIM ; Sang Yun LEE ; Su Seong PARK
Archives of Craniofacial Surgery 2017;18(2):82-88
BACKGROUND: Turbinate hypertrophy is one of the common causes of chronic nasal obstruction. In principle, therapeutic guidelines recommend medical treatment. Failure to treat turbinate thickening despite drug therapy may indicate the need for surgery. The main aim of this study was to determine the effect of radiofrequency surgery, among various other surgical procedures, on people with both nasal septal deviation and turbinate hypertrophy. METHODS: Among people with nasal deviation who visited the subject hospital between July 2008 to July 2014, 21 people with nasal septal deviation and severe turbinate hypertrophy before their surgery had undergone septoplasty with turbinoplasty using radiofrequency combined with septoplasty. The degree of the turbinate's hypertrophy was appraised in all the patients before and after the surgery using the rhinoscopy, and acoustic rhinometry was objectively carried out. The subjective effect of the turbinoplasty using radiofrequency was explored through the visual analog scale (VAS) score. RESULTS: The degree of contraction of the nasal mucosa after the rhinoscopy changed from Grades 3 and 4 (100%) to Grades 1 and 2 (95.2%) and Grades 3 (4.8%). The minimal cross-sectional area significantly increased from 0.44±0.07 to 0.70±0.07 cm² (p<0.05). The nasal cavity volume increased from 4.79±0.49 to 6.76±0.55 cm² (p<0.05). The subjective symptoms evaluated with VAS score a year after the surgery significantly improved (p<0.05). CONCLUSION: Turbinoplasty using Coblator with septoplasty is an effective treatment method because it expands nasal cavity, has a low incidence of complications, subjectively improves symptoms, and has short treatment duration.
Drug Therapy
;
Humans
;
Hypertrophy
;
Incidence
;
Methods
;
Nasal Cavity
;
Nasal Mucosa
;
Nasal Obstruction
;
Rhinometry, Acoustic
;
Rhinoplasty
;
Turbinates
;
Visual Analog Scale
4.Is Rectosigmoid Vaginoplasty Still Useful?.
Seok Kwun KIM ; Ji Woen PARK ; Kwang Ryeol LIM ; Keun Cheol LEE
Archives of Plastic Surgery 2017;44(1):48-52
BACKGROUND: The ideal vaginoplasty must be successful functionally as well as have a natural appearance, and also must retain its functionality and appearance over the long term. Conventional vaginoplasty techniques have functional limitations and are associated with recurrent complications, but rectosigmoid vaginoplasty is known to have a high satisfaction rate due to its functional similarity with the vagina. We conducted the present study to assess the usability of rectosigmoid vaginoplasty over the course of long-term follow-up. METHODS: From March 1992 to February 2014, 84 patients were treated with rectosigmoid vaginoplasty; 44 had gender identity disorder, 29 had vaginal agenesis, 8 had female pseudohermaphroditism, and 3 had gynecologic malignancies after radical pelvic surgery. This retrospective study was based on a review of the patients' records, clinical examinations, complications, and questionnaires about appearance, function, and sexual intercourse. RESULTS: All patients who underwent rectosigmoid vaginoplasty were discharged within 2 weeks without surgical flap loss. The early complications were partial flap necrosis, difficulty in defecation, mucous hypersecretion, and postoperative ileus. The late complications were vaginal introitus contracture, vaginal prolapse, and difficulty in urination. The mean length and diameter of the neovagina 3.4 years after rectosigmoid vaginoplasty were 13.2 cm and 3.8 cm, respectively. On questionnaires about satisfaction, 70% of patients reported excellent satisfaction, 11% good, 12% fair, and 7% poor. CONCLUSIONS: Rectosigmoid vaginoplasty is useful, safe, and well-accepted operative method with good functional and cosmetic results, such as natural lubrication and adequate vaginal length and width obtained without requiring the use of a dilator.
46, XX Disorders of Sex Development
;
Coitus
;
Contracture
;
Defecation
;
Follow-Up Studies
;
Gender Identity
;
Humans
;
Ileus
;
Lubrication
;
Methods
;
Necrosis
;
Retrospective Studies
;
Surgical Flaps
;
Urination
;
Uterine Prolapse
;
Vagina
5.Endoscopic Submucosal Dissection Using a Novel Versatile Knife: An Animal Feasibility Study (with Video).
Chang Il KWON ; Gwangil KIM ; Il Kwun CHUNG ; Won Hee KIM ; Kwang Hyun KO ; Sung Pyo HONG ; Seok JEONG ; Don Haeng LEE
Clinical Endoscopy 2014;47(6):544-554
BACKGROUND/AIMS: In order to reduce the procedure time and the number of accessory changes during endoscopic submucosal dissection (ESD), we developed a novel versatile knife, which has the combined advantages of several conventional knives. The aim of this study was to compare the efficacy, safety, and histological quality of ESD performed using this novel versatile knife and a combination of several conventional knives. METHODS: This was an in vivo animal study comparing two different modalities of ESD in mini-pigs. Completion time of each resection was documented, and the resected specimens were retrieved and evaluated for completeness. To assess the quality control of the procedures and adverse events, detailed histopathological examinations were performed. RESULTS: A total of 18 specimens were dissected by ESD safely and easily (nine specimens using the new versatile knife; nine specimens by mixing conventional knives). All resections were completed as en bloc resections. There was no significant difference in procedure time between the 2 modalities (456 seconds vs. 355 seconds, p=0.258) and cutting speed (1.983 mm2/sec vs. 1.57 mm2/sec, p=1.000). The rate of adverse events and histological quality did not statistically differ between the modalities. CONCLUSIONS: ESD with a versatile knife appeared to be an easy, safe, and technically efficient method.
Animals
;
Equipment and Supplies
;
Feasibility Studies*
;
Models, Animal
;
Quality Control
6.Relationship between 15-hydroxyprostaglandin dehydrogenase and gastric adenocarcinoma.
Jae Hyun KANG ; Sang Hyun KANG ; Sang Hyuk SEO ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Mi Seon KANG ; Kwang Hee KIM
Annals of Surgical Treatment and Research 2014;86(6):302-308
PURPOSE: Prostaglandin E2 (PGE2) is a contributory carcinogen in gastric adenocarcinoma. 15-Hydroxyprostaglandin dehydrogenase (15-PGDH) catabolizes PGE2 by oxidizing its 15(s)-hydroxy group. The aim of this study was to investigate the expression of 15-PGDH in gastric adenocarcinoma tissue and the relationship between 15-PGDH expression and clinicopathologic features of gastric adenocarcinoma. METHODS: Ninety-nine patients who underwent surgical resection for gastric adenocarcinoma between January 2007 and December 2007 were enrolled and evaluated retrospectively. RESULTS: In 62 patients (62.6%), 15-PGDH expression was lower in gastric adenocarcinoma tissue than in nonneoplastic tissue. Regarding the relationship between 15-PGDH expression and clinicopathological features, 15-PGDH expression was significantly lower in tissues with poor differentiation (P = 0.002), advanced T stage (P = 0.0319), a higher number of lymph node metastases (P = 0.045), lymphatic invasion (P = 0.031), and vascular invasion (P = 0.036). CONCLUSION: 15-PGDH expression was associated with a subset of clinicopathologic features such as differentiation grade, T stage, lymphatic invasion, and vascular invasion.
Adenocarcinoma*
;
Dinoprostone
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Oxidoreductases*
;
Retrospective Studies
;
Stomach Neoplasms
7.A Clinical and Epidemiological Study of Scabies in Korea: A Multicenter Prospective Study.
Song Youn PARK ; Joo Young ROH ; Jun Young LEE ; Do Won KIM ; Tae Jin YOON ; Woo Young SIM ; Kyu Suk LEE ; Young Chul KYE ; Ai Young LEE ; Moon Bum KIM ; Soyun CHO ; Kee Chan MOON ; Jun Mo YANG ; Eun So LEE ; Won Soo LEE ; Min Geol LEE ; Seok Don PARK ; Young Ho WON ; Bong Seok SHIN ; Chang Kwun HONG ; Jeunghoon LEE ; Tae Young YOON ; Kwang Joong KIM ; Young Suck RO ; Ki Ho KIM ; Hee Chul EUN
Korean Journal of Dermatology 2014;52(7):457-464
BACKGROUND: Scabies is an old and common contagious skin disease. The incidence of scabies has decreased through the economic growth of Korea. However, recent outbreaks in medical facilities have created a suspicion that the infection of scabies is an emerging public health problem. OBJECTIVE: We evaluated the epidemiological and clinical aspects of patients diagnosed with scabies in Korea. This prospective study follows the retrospective study already performed by the same authors in 2011. METHODS: A multicenter, prospective study of scabies was performed at 25 hospitals in Korea. We included 914 patients who were diagnosed with scabies. Microscopic examination revealed scabies mites or eggs, or clinical improvement after treatment. Patients were asked to provide information on scabies, especially regarding the contact source, and the physicians examined them. RESULTS: Of the participants, 432 patients were men and 482 were women. Patients aged younger than 10 years and 60~69 years were the most common groups. Scabies more commonly affected patients during the fall and winter. Of the patients, 68.0% were thought to be infected at their homes, followed by nursing homes or hospitals (25.7%), and 31.6% through contact with other patients or, occasionally, staff members, including caregivers. CONCLUSION: We confirmed that scabies is an emerging threat in institutions, especially medical facilities. In addition, we suggest that public and in-hospital education is essential to minimize the problems associated with scabies.
Caregivers
;
Disease Outbreaks
;
Economic Development
;
Education
;
Eggs
;
Epidemiologic Studies*
;
Epidemiology
;
Female
;
Humans
;
Incidence
;
Korea
;
Male
;
Mites
;
Nursing Homes
;
Ovum
;
Prospective Studies*
;
Public Health
;
Scabies*
;
Skin Diseases
8.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
9.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
10.Association Between a Close Distal Resection Margin and Recurrence After a Sphincter-Saving Resection for T3 Mid- or Low-Rectal Cancer Without Radiotherapy.
Jae Woong HAN ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Min Kyung OH ; Mi Seon KANG ; Kwan Hee HONG
Annals of Coloproctology 2013;29(6):231-237
PURPOSE: To maintain the patient's quality of life, surgeons strive to preserve the sphincter during rectal cancer surgery. This study evaluated the oncologic safety of a sphincter-saving resection with a distal resection margin (DRM) <1 cm without radiotherapy in T3, mid- or low-rectal cancer. METHODS: This retrospective study enrolled 327 patients who underwent a sphincter-saving resection for proven T3 rectal cancer located <10 cm from the anal verge and without radiotherapy between January 1995 and December 2011. The oncologic outcomes included the 5-year cancer-specific survival, the local recurrence, and the systemic recurrence rates. RESULTS: In groups A (DRM < or =1 cm) and B (DRM >1 cm), the 5-year cancer-specific survival rates were 81.57% and 80.03% (P = 0.8543), the 5-year local recurrence rates were 6.69% and 9.52% (P = 0.3981), and the 5-year systemic recurrence rates were 19.46% and 23.11% (P = 0.5750), respectively. CONCLUSION: This study showed that the close DRM itself should not be a contraindication for a sphincter-saving resection for T3 mid- or low-rectal cancer without radiotherapy. However, a prospective randomized controlled trial including the effect of adjuvant therapy will be needed.
Humans
;
Quality of Life
;
Radiotherapy*
;
Rectal Neoplasms
;
Recurrence*
;
Retrospective Studies
;
Survival Rate

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